NCT06261619

Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

A Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Manual Ventilation Alone in Patients Undergoing Non-emergent Surgery With General Anesthesia: A Prospective Randomized Cross-over Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Detailed description

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this superiority study, the investigators will use a two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone with respect to airway pressure.

Conditions

• Airway Management
• Respiration, Artificial

Interventions

Type	Name	Description
DEVICE	Adult Sotair Device	Adult Sotair® device employs a flow limiting valve mechanism.

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-03-18
• Completion: 2025-03-18
• First posted: 2024-02-15
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study